Breast CancerPhase 2STOPNCT02674204
STOP Heart Disease in Breast Cancer Survivors Trial
A Phase 2 study testing Atorvastatin in people with Breast Cancer and Heart Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Heart Disease, Cardiotoxicity
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2016to 25 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with newly diagnosed stage 1-3 breast cancer
- Histologically confirmed HER2, ER, and PR status
- Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients will be eligible for up to 3 weeks after starting treatment.
- Age minimum 18 years
- Able and willing to read, understand, and sign an informed consent form (ICF) and medical release form
- Willing and able to comply with trial protocol and follow-up
- ECOG performance status 0-1 (Karnofsky ≥ 70%)
Who cannot join
- Prior use of statin medication within the past year
- Not using statin medication but is eligible for statin therapy based on the 2013 ACC/AHA guidelines (LDL cholesterol >190, or LDL <190 and ASCVD risk >7.5%; http://tools.acc.org/ASCVD-Risk-Estimator/) and is > 50 years old; or is eligible for statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes to be placed on statin therapy
- History of adverse effects, intolerance, or allergic reactions attributed to statin medication
- Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin, the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or red yeast rice
- Current use of any other investigational agent
- Pregnant or intention to get pregnant during the next 18 months. Pregnant women are excluded from this study because atorvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects, and MRI is contraindicated in pregnant women.
Show all 15Show fewer
- History of diabetes, severe lung disease, renal disease (creatinine > 1.8 mg/dL or CrCl ≤ 50 mL/min), or hepatic disease (AST and ALT > 3 times upper normal limits)
- Abnormal baseline echocardiogram or cardiac MRI (detection of congenital heart disease; ischemic heart disease; moderate or severe valvular heart disease; cardiomyopathy; EF < 55%)
- Previously known or diagnosed heart disease (e.g. congenital; valvular; coronary artery disease; history of myocardial infarction or acute coronary syndrome; cardiomyopathy, including infiltrative, hypertensive, hypertrophic, dilated, constrictive pericarditis, or other cardiomyopathy)
- Left ventricular dysfunction (EF < 55%)
- Prior non-cardiac illness with an estimated life expectancy < 4 years
- Known active infection with HIV
- Allergy or contraindication to MRI testing, including claustrophobia, metallic parts in body the prohibiting MRI, prior gadolinium contrast reaction, or uncontrolled moderate hypertension (sitting blood pressure >160/95 mm Hg with measurements recorded on at least 2 occasions).
- Has metallic breast expanders in place at the time of screening
- Concurrent illness which in the opinion of the investigators would compromise either the patient or the integrity of the data
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial
The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.
Read the detailed description
This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.
- Conditions
- Breast Cancer, Heart Disease, Cardiotoxicity, Myocardial Dysfunction
- Being tested
- Atorvastatin, Placebo
- Keywords
- Statin therapy, trastuzumab
- Medical subject headings
- Breast Neoplasms, Heart Diseases, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor, Atorvastatin calcium
Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
PlaceboDrug
A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
| Study group | Role | What they receive |
|---|---|---|
| Study Agent | Experimental | One atorvastatin 20 mg oral capsule per day Receives: Drug: Atorvastatin |
| Control | Placebo comparator | One matching placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
Measured: baseline to 12 months post initiation of statin intervention
Secondary outcomes (14)
Change in Global Longitudinal Strain as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Twist as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Torsion as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Left Ventricular Untwisting Rate as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Left Ventricular Ejection Fraction as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Left Ventricular End Diastolic Volume as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Left Ventricular End Systolic Volume as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Cardiac Output as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Left Ventricular Mass as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Left Ventricular Concentricity as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Native T1 as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Post Contrast T1 as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Extracellular Volume as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Change in Native T2 as Measured by CMRI
Measured: Baseline to 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start5 May 2016
- Primary completion25 May 2018
- Study completion25 May 2018
Why it stopped: Closed due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Responsible party
- Principal investigator, Marc Goodman, Cedars-Sinai Medical Center
- Investigators
- Marc Goodman, PhD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674204
- Sponsor's protocol ID
- IIT2015-12-Goodman-STOP
- Acronym
- STOP
- Status last verified
- May 2019
- First submitted
- 21 Jan 2016
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Therapy Operates to Prevent (STOP) Heart Disease in Breast Cancer Survivors Trial
- ClinicalTrials.gov ID
- NCT02674204
- Acronym / sponsor ID
- STOP / IIT2015-12-Goodman-STOP
- Conditions
- Breast Cancer, Heart Disease, Cardiotoxicity, Myocardial Dysfunction
- Keywords
- Statin therapy, trastuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- California Breast Cancer Research Program
- Study start
- 5 May 2016 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Posted 30 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to to examine the effects of atorvastatin, a type of statin, on changes to the heart among women undergoing breast cancer treatment. Atorvastatin may reduce or eliminate the harmful effects of chemotherapy treatment to the heart tissue of breast cancer patients.
Detailed description
This is a placebo-controlled study. It will compare the effects of atorvastatin against the effects of a placebo (an inactive substance, such as, a sugar pill) on changes to the heart before and during breast cancer treatment. Participants will be in the study for approximately a year and a half, and the study will enroll up to 60 patients. During that time, there will be six visits that may coincide with standard of care visits. Participants will also receive telephone calls from study staff during the study intervention and a follow-up phase to check-in with them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Agent | Experimental | Drug: AtorvastatinOne atorvastatin 20 mg oral capsule per day |
| Control | Placebo comparator | Drug: PlaceboOne matching placebo daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients with newly diagnosed stage 1-3 breast cancer
- Histologically confirmed HER2, ER, and PR status
- Recommended to undergo trastuzumab treatment, with or without anthracycline. Patients will be eligible for up to 3 weeks after starting treatment.
- Age minimum 18 years
- Able and willing to read, understand, and sign an informed consent form (ICF) and medical release form
Key exclusion criteria (15 listed)
- Prior use of statin medication within the past year
- Not using statin medication but is eligible for statin therapy based on the 2013 ACC/AHA guidelines (LDL cholesterol >190, or LDL <190 and ASCVD risk >7.5%; http://tools.acc.org/ASCVD-Risk-Estimator/) and is > 50 years old; or is eligible for statin therapy based on the 2013 ACC/AHA guidelines and is 40-50 years old and wishes to be placed on statin therapy
- History of adverse effects, intolerance, or allergic reactions attributed to statin medication
- Current use of gemfibrozil, cyclosporine, clarithromycin, itraconazole, erythromycin, the hepatitis C protease inhibitor telaprevir, HIV protease inhibitors, colchicine, or red yeast rice
- Current use of any other investigational agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor, Atorvastatin calciumAtorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. | Drug | Study Agent |
| PlaceboA substance that has no therapeutic effect, and will be used as a control in testing the study agent. | Drug | Control |
Primary outcome
Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)
Time frame: baseline to 12 months post initiation of statin intervention
14 secondary outcomes
Change in Global Longitudinal Strain as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Twist as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Peak Left Ventricular Torsion as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Untwisting Rate as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Ejection Fraction as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular End Diastolic Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular End Systolic Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Cardiac Output as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Mass as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Left Ventricular Concentricity as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Native T1 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Post Contrast T1 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Extracellular Volume as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Change in Native T2 as Measured by CMRI
Time frame: Baseline to 12 months of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Goodman, PhD principal investigator
Cedars-Sinal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Breast Cancer and Heart Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI) (time frame: baseline to 12 months post initiation of statin intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.